Effect of RAS on Balance and Gait After Stroke

NCT ID: NCT03974490

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-01-31

Brief Summary

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A rhythmic auditory stimulation intervention may be beneficial in order to improve movement parameters after stroke. Reviews argue that more randomized controlled trials with a control group are needed. Main objective: Evaluate the effect of a rhythmic auditory stimulation on the quality of balance and gait parameters in people with stroke. Methodology: quasi-experimental study. The study has been approved by the hospital ethics committee.

Detailed Description

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A rhythmic auditory stimulation (RAS) intervention may be beneficial in order to improve the parameters of the post-stroke movement: increase of the speed of the walk, improvement in the width of the step with the affected side, improvement of the walking index dynamics (Dynamic Gait Index), improvement in cadence and improvement in the static balance.

Current systematic reviews argue that more randomized controlled trials with a control group are needed.

Main objective: To evaluate the effect of a rhythmic auditory stimulation on the quality of progress and balance in people with stroke.

Methodology: experimental group will be done between 2019 and 2020 and historical control group of the years 2017 and 2018. Experimental group will do 3 sessions in a week of RAS, and daily 2 hours of physiotherapy except of Sundays. Control group received 2 hours daily of physiotherapy, except Sundays.

The study has been approved by the hospital ethics committee.

Conditions

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Stroke Gait, Hemiplegic Gait Disorders, Neurologic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

2 hours from Monday to Saturday, conventional physiotherapy: strengthening, stretching, dual task training.

3 Times a week, intervention: Start with global body warming, 15 minutes, following the rhythm marked by the metronome. Central part of the session, 60 minutes, with rhythmic auditory stimulation exercises and music. Closure of the session, 15 minutes, round of impressions.

Group Type EXPERIMENTAL

Rhythmic auditory stimulation

Intervention Type OTHER

Rhythmic auditory stimulation 3 times in a week, and 2 hours of physiotherapy 6 days in a week.

Historical control group

2 hours from Monday to Saturday, conventional physiotherapy: strengthening, stretching, dual task training.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rhythmic auditory stimulation

Rhythmic auditory stimulation 3 times in a week, and 2 hours of physiotherapy 6 days in a week.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Had a stroke in the last 3 weeks
* Rankin 3-4
* Barthel before stroke: \>85
* Tinetti \< 23

Exclusion Criteria

* Patient can walk independently (Functional Ambulation Category \>3)
* Global and/or mixed aphasia
* Glasgow \< 10
* Mini-Mental State Examination \< 24
* Posterior cerebral artery stroke
* Gait and/or balance disorders before stroke (parkinsons disease, neurodegenerative diseases)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sociosanitari Mutuam Girona

OTHER

Sponsor Role lead

Responsible Party

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Samira Gonzalez Hoelling

Principal Investigator, Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samira Gonzalez

Role: PRINCIPAL_INVESTIGATOR

Hospital Sociosanitari Mutuam Girona

Locations

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Hospital Sociosanitari Mutuam Girona

Girona, , Spain

Site Status

Countries

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Spain

References

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Gonzalez-Hoelling S, Bertran-Noguer C, Reig-Garcia G, Suner-Soler R. Effects of a Music-Based Rhythmic Auditory Stimulation on Gait and Balance in Subacute Stroke. Int J Environ Res Public Health. 2021 Feb 19;18(4):2032. doi: 10.3390/ijerph18042032.

Reference Type DERIVED
PMID: 33669715 (View on PubMed)

Other Identifiers

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Mutuam_Girona_04_19

Identifier Type: -

Identifier Source: org_study_id

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